FDA One Step Away From Declaring Dietary Supplements Drugs
by Bill Sardi by Bill Sardi
President Barack Obama has appointed two experts, one in food the other in drugs, to head up the soon to be reorganized Food & Drug Administration in preparation for an agency split that would separate the FDA into two — one agency to oversee foods and the other to regulate drugs. But just exactly where does that leave dietary supplements?
The Dietary Supplement Health & Education Act of 1994 (DSHEA) declares dietary supplements to be products intended to supplement the diet. But the FDA contends DSHEA severely limits the FDA in regulating a growing industry. A recently issued report from the General Accounting Office claims the FDA does not have the resources to adequately regulate dietary supplements. The GAO report appears to be part of an orchestrated effort to soften the public up for a major change in the classification and regulation of dietary supplements.
Unlike drugs which must be approved for safety and efficacy before entering the market, dietary supplements marketed before 1994 are presumed to be safe. FDA must demonstrate that a product presents a significant or unreasonable risk to the public to get it off the market. But that may change.
An ominous sign of things to come — the FDA just classified a form of vitamin B6 (pyridoxine) as a new drug (Pyridorin, Biostratum).
Despite recent outbreaks of foodborne disease (Salmonella in peanuts) and approval of deadly or problematic drugs (recently Vioxx, Seroquel, many others) compared against few if any reported deaths in the newly implemented Adverse Event Reporting for dietary supplements, the Federal government is aiming its regulatory muscle at vitamin, mineral and herbal pills.
Despite the fact that dietary supplements are far safer than table salt, aspirin, vaccines and many FDA-approved drugs, they are being demonized. Year after year, surveys conducted by poison control centers show dietary supplements to be the safest products of all.
In a misdirection, it appears food supplements are being mischaracterized as potentially dangerous and in need of greater regulatory oversight. This leads to the possibility of FDA placing supplements under the same regulatory body that oversees drugs.
The FDA appears to be covering for the sins of the drug companies, which is pushing for faster approval of new drugs, which led to the Vioxx fiasco (it is estimated 20,000 Americans died prematurely from taking this anti-inflammatory drug that should have never been approved by the FDA). Vioxx, if you recall, was touted as being safer than other anti-inflammatory drugs such as ibuprofen and aspirin.
Just recently it was revealed that salespeople for a U.S. drug company told doctors that an anti-psychotic drug (Seroquel- $4.45 billion in sales 2008) didn’t cause diabetes more than two years after the drug maker warned physicians in Japan of possible links to the disease. Twelve serious cases (including 1 death) of hyperglycaemia, diabetic ketoacidosis and diabetic coma here causally linked with the drug. What penalties a drug company will receive from the FDA for this type of apparent misdeed is unknown.
Massive efforts have been taken to convince the public to be wary of dietary supplements. Just when DSHEA was being deliberated for passage in Congress in October of 1994, suddenly a report was published in New England Journal of Medicine claiming beta carotene pills increased the risk of death among smokers in Finland. But examination of the published paper showed beta carotene hardly increased mortality rates at all (by less than 1%).
For years the FDA drug its feet in publishing Good Manufacturing Practices (GMP) for the dietary supplement industry, while pointing fingers at and sanctioning supplement makers who made marginal quality products, often mislabeled for dosage or for making false advertising claims. Only recently has the FDA completed GMP guidelines for food supplements.
In 2006 the FDA drew fire when it declared tart cherry supplements to be “new drugs” because manufacturers claimed their products had potent anti-inflammatory properties. Another agency of the government, the US Department of Agriculture, published a study showing tart cherry extract is as effective as ibuprofen in reducing inflammation. Ibuprofen can cause gastric problems that can lead to bleeding ulcers and even death. Tart cherry extract has no reported side effects. In this manner the FDA restricts free speech and the public is deprived of learning ways to stay healthy naturally and practice self care.
In 1994 Americans wrote more letters to Congress to maintain access to dietary supplements than on any other piece of legislation to date.